Summary
Overview
Work History
Education
Skills
Certification
Previous Experience
Currentprofile
Academicqualification
Personal Information
Languages
Timeline
Generic
Amey Chouthai

Amey Chouthai

Engagement Delivery Lead
Dombivali (East)

Summary

Service -focused Engagement Delivery Lead designated as Deputy General Manager dedicated to delivering positive customer experiences. Honed skills to navigate ad thrive for dynamic environments, consistently seeking growth and excellence with a robust track record of 17+ years in Clinical Data Management. Forward thinking to vision with commitment to adapting to rapidly evolving global clinical data management landscape.

Overview

14
14
years of professional experience
5
5
years of post-secondary education
4
4
Certifications

Work History

Deputy General Manager

Cognizant Technologies Solutions
Mumbai
07.2024 - Current
  • Maintained primary relationship accountability for clients, overall servicing responsibility of data management delivery and client satisfaction to maximize profitability of client relationships for prominent sponsor .
  • Served as primary point of contact for sponsor, addressing data management concerns promptly and professionally.
  • Managed diverse team of 200+ professionals, ensuring high-quality service delivery for all projects.
  • Ensured compliance to Service Level Agreements and Key Performance Indicators to meet contractual requirement for engagement along with relevant regulatory requirement.
  • Devised innovative solutions for overcoming resistance to change within engagement by engaging stakeholders in open dialogues about their concerns and expectations.

Service Delivery Manager

Cognizant Technology Solutions
Mumbai
09.2021 - 06.2024
  • Worked as operational lead for portfolio of 70 studies within assigned therapeutic area.
  • Performed review of portfolio level metrics, Ensured compliance with relevant regulations by developing robust policies and procedures.
  • Enhanced service delivery by developing and implementing efficient processes.
  • Optimized resource allocation by analyzing operational data and adjusting staffing levels according to demand fluctuations.
  • Worked as Change Management Lead and subject matter expert for process
  • Maintained process improvements to further enhance productivity of deliveries by implementing and assisting process and technology changes.
  • Conducted comprehensive assessments of organizational needs, identifying areas for improvement and implementing targeted solutions.

Team Manager

Cognizant Technologies Solutions
Mumbai
10.2019 - 08.2021
  • Provided oversight to data management deliverables for assigned set of studies.
  • Worked as Subject Matter Expert and guided team on data management task
  • Trained Data Management professionals on Start up, Conduct and Close out activities which are in scope
  • Developed performance measurement strategies, identifying areas for improvement.
  • Facilitated meetings to communicate team performance goals and results.
  • Cultivated positive, productive team environments, resolving conflicts quickly.

Team Leader

Cognizant Technologies Solutions
Mumbai
08.2016 - 09.2019
  • Worked as Project Data Manager -primary point of contact for sponsor and study team for specific clinical trial.
  • Collaborated with cross-functional teams to drive successful execution of clinical trials.
  • Reduced data discrepancies through implementation of robust validation checks and error resolution procedures.
  • Created data management plans and provided input on study designs.
  • Worked on post production changes starting from protocol impact assessment, database upgrades and migrations and user acceptance testing
  • Assisted in preparation of regulatory submissions by generating high-quality datasets and relevant documentation.
  • Led team of data management specialists to ensure timely completion of project deliverables

Associate Consultant

ValueLabs LLP
Mumbai
09.2015 - 07.2016
  • Performed comprehensive data management tasks, clinical data programming, training, value proposition creation, and worked on Microsoft Power BI projects.

Assistant Manager

Tata Consultancy Services Ltd
Mumbai
01.2011 - 08.2015
  • Handled cross-functional team, planned and organized clinical programming and data management tasks, provided technical expertise, performed data management tasks, conducted user acceptance testing, attended customer meetings, implemented process improvements, and received performance awards.

Senior Scientific (Data) Analyst

Molecular Connections Pvt. Ltd
Bangalore
6 2007 - 12.2010
  • Managed pre-clinical study data, retrieved pharmacodynamics and pharmacokinetic data, resolved data discrepancies, monitored work flow, allocated tasks, and trained subordinates.

Education

PG Diploma - Business Management

IMT Ghaziabad (Distance Learning)
Ghaziabad
07.2008 - 01.2009

Master of Science - Biotechnology

Bangalore University
Bengaluru, India
08.2005 - 06.2007

Bachelor of Science - Biotechnology

Shivaji University
Kolhapur, India
06.2002 - 06.2005

Skills

Comprehensive knowledge of data management process, database structures and EDC systems

Ability to lead by motivation, coordination with team for task prioritization and delegation

Medidata Certified Study builder for Rave EDC, proficient in rave system functionality

Experience in other Clinical technologies and reporting tools like LSH, Spotfire, JReview

Provide Subject Matter Expertise for implementing in house Centralized Data Review Platform

Identify, coordinate, suggest and implement process improvements within the work environment

Knowledge about ICH-GCP, GLP and clinical data management

MS office (Word, Excel, PowerPoint)

Experience with Veeva EDC and eTMF systems

Certification

Six Sigma (Yellow belt) certificate from OVI India Ltd.

Previous Experience

  • Associate Consultant (Clinical Services), ValueLabs LLP, Mumbai, 09/2015, 07/2016, Perform and/or initiate comprehensive data management tasks, pertaining to Database design, programming, validation and Data transfers, Responsible for the Clinical Data Programming including clinical database support for FSP client projects, quality of clinical data programming deliverables, personnel and technical leadership., Conduct training pertaining to rave study build and edit check programming activities, user acceptance testing, Create value propositions for the customers on CDM solutions, Develop CDM solution such as Risk based monitoring and ePro solutions and scope of analytics in CDM industry
  • Assistant Manager, Tata Consultancy Services Ltd, Mumbai, 01/2011, 08/2015, Responsible for handling a cross functional team comprises data managers and clinical programmers, Responsible for planning, organizing and resourcing clinical programming and data management tasks on projects to ensure optimum efficiency, Provide technical expertise to Clinical data management and programming team, Perform and initiate comprehensive data management tasks, pertaining to Database design, programming, and conduct of clinical trials, Perform User acceptance testing for RAVE database comprising confirmation of study logic and check configuration is correct as specified in the specification documents, Perform verification of the required data elements (e.g. forms, fields, formats), as well as on edit checks and custom functions for each of the respective integrations, Perform study conduct activities like discrepancy management, non-eCRF data reconciliation, Attend weekly customer meetings to discuss study status, Develop and maintain good communication and working relationships with CDM and programming teams, Provide mentoring to Rave UAT team. Certified “Train the trainer” for the process, Perform quality control procedures for relevant activities, To understand and comply with core operating procedures and working instructions
  • Senior Scientific (Data) Analyst, Molecular Connections Pvt. Ltd, Bangalore, 06/2007, 12/2010, Managed Pre-clinical study data including small molecule (drug) entities with there biological activities using SQL platform., Retrieved Pharmacodynamics (efficacy) and Pharmacokinetic (ADMET) parameter related data along with the target for the drug., Resolved data discrepancies identified by the system or through manual checks as per standard guidelines, Attended meetings to give the status of work to client and update as per their requirement., Monitored the work flow and allocate the task to the subordinates., Trained the subordinates.

Currentprofile

Currently working as Service Delivery Manager in Cognizant Technology Solutions, Mumbai from August 2016 till date

Academicqualification

Business management from IMT, Ghaziabad in 2009., M. Sc (Biotechnology) from Bangalore University (India) in 2007., B.Sc (Biotechnology) from Shivaji University (India) in 2005.

Personal Information

  • Visa Type: Business Visa (B1)
  • Date of Birth: 06/05/1985

Languages

English
Marathi
Hindi

Timeline

Deputy General Manager

Cognizant Technologies Solutions
07.2024 - Current

Service Delivery Manager

Cognizant Technology Solutions
09.2021 - 06.2024

Team Manager

Cognizant Technologies Solutions
10.2019 - 08.2021

Team Leader

Cognizant Technologies Solutions
08.2016 - 09.2019

Associate Consultant

ValueLabs LLP
09.2015 - 07.2016

Assistant Manager

Tata Consultancy Services Ltd
01.2011 - 08.2015

PG Diploma - Business Management

IMT Ghaziabad (Distance Learning)
07.2008 - 01.2009

Master of Science - Biotechnology

Bangalore University
08.2005 - 06.2007

Bachelor of Science - Biotechnology

Shivaji University
06.2002 - 06.2005

Senior Scientific (Data) Analyst

Molecular Connections Pvt. Ltd
6 2007 - 12.2010
Amey ChouthaiEngagement Delivery Lead